We previously reported on the U.S. Food and Drug Administration’s (the “FDA”) Guidance providing for a one year enforcement discretion period for the Drug Supply Chain Security Act (“DSCSA”) requirement of electronic interoperability for tracking transactions and several other provisions to November 27, 2024. The FDA has heard from many stakeholders that the 1-year enforcement delay needs to be extended as a significant number of manufacturers and distributors are still not providing transaction data using an interoperable electronic system. Products without serialized electronic data records cannot be distributed or dispensed by pharmacies to patients unless they meet a small dispenser exemption.
The upcoming DSCSA requirements include:
- Interoperable exchange for transaction information (TI) and transaction statements (TS) with the TI including a package-level identifier;
- Interoperable verification; and
- Interoperable tracing via a secure interoperable, electronic system.
Besides the approaching end to enforcement discretion for interoperable electronic transmission of transaction data between trading partners, enforcement discretion ends for many other provisions including creating Standard Operating Procedures (“SOPs”) for purchasing, maintaining records, conducting investigations of suspect product, T2 clerical errors, responding to requests from other trading partners and regulatory agencies for suspect product, reporting illegitimate products, sales to other pharmacies, generating Electronic Product Code Information Services (“EPCIS”), and product returns. Pharmacies will need a Global Location Number (“GLN”) for each physical location as well. Furthermore, they will need to understand the effects on the 5% Rule and pharmacies will need to prepare for DSCSA inspections by Boards of Pharmacy which may occur with or without FDA involvement.
To mitigate supply chain disruptions of prescription drugs, in June 2024, the FDA announced a two (2) year small dispenser exemption for pharmacies with 25 or fewer employees. To supplement the small dispenser exemptions, the FDA is accepting “Waivers, Exceptions, and Exemptions” commonly referred to as “WEEs” from any trading partner to document lack of readiness. Although the FDA requested submission of WEEs by August 1, 2024, it is still accepting them since this was not a statutory deadline for filing.
How Can Frier Levitt Help
Pharmacies need to have robust Policies and Procedures for drug purchasing, maintaining appropriate purchase and salable return information, identification and investigation of suspect product, and reporting obligations for illegitimate product. If your pharmacy has more than 25 employees, a WEE may be an option. Frier Levitt attorneys can assist in drafting SOPs in compliance with the new DSCSA requirements as well as WEEs. We can assist with the additional requirements expected from both FDA and Boards of Pharmacy for DSCSA compliance for license renewals and inspections. Contact us today to speak with an attorney.
